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Anisodamine hydrobromide reduces 28-day mortality in septic shock: a randomized controlled

In brief

Anisodamine cut 28-day death hazard by 36% in septic shock trial

Among 296 patients with septic shock, those given anisodamine plus standard care had a 36% lower hazard of death by day 28 than those receiving standard care alone. Lactate levels and clearance at 24 hours statistically explained part of the benefit, but this single trial does not establish how broadly the findings apply or confirm the mechanism.

Journal
Frontiers in pharmacology (Q1)
Published
22 September 2026
Study design
Randomized controlled trial
Evidence level
Level 1, High (CEBM 1b)
Authors
Xueting Yang, Hongqiong Peng, Tianmeng Pan, Ting Xie, Lei Deng, Ping Zhou, et al.
PMID
42840310
DOI
10.3389/fphar.2026.1852584

Why clinicians should know about it

Abstract

BACKGROUND: This randomized controlled trial evaluated whether anisodamine hydrobromide reduces 28-day mortality in septic shock and whether this effect is mediated by lactate and lactate clearance. METHODS: In this prospective randomized controlled trial, 296 patients with septic shock were randomly assigned to receive anisodamine hydrobromide plus standard therapy (n = 148) or standard therapy alone (n = 148). The primary outcome was 28-day all-cause mortality. Causal mediation analyses were performed to assess the mediating roles of lactate and lactate clearance rate at 24, 48, and 72 h. RESULTS: Anisodamine significantly reduced 28-day mortality compared with control (hazard ratio 0.64, 95% confidence interval 0.43-0.95; P = 0.028). Causal mediation analysis revealed that lactate at 24 h (average causal mediation effect -0.0166, P = 0.042) and lactate clearance rate at 24 h (average causal mediation effect -0.0206, P = 0.016) significantly mediated the protective effect, explaining 14.1% and 17.3% of the total effect, respectively. Lactate at 72 h also showed significant mediation (P = 0.032), with a mediated proportion of 21.6%. Sensitivity analysis using complete cases confirmed the robustness of these findings (hazard ratio 0.60, 95% confidence interval 0.40-0.91; P = 0.014), with consistent mediation effects for lactate and lactate clearance at 24 h. CONCLUSION: Anisodamine hydrobromide significantly reduces 28-day mortality in patients with septic shock, with effects partially mediated by lactate and lactate clearance at 24 h. These findings support the integration of anisodamine into sepsis management protocols.

Abstract as published, via PubMed.

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For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.